If cleared by the FDA, the Proof Lab Test System can be used to provide accurate, actionable, laboratory-grade results for COVID-19 (SARS-CoV-2) in as little as 18 minutes
CAMBRIDGE, Mass., April 7, 2022 /PRNewswire/ — Proof Diagnostics, Inc., an innovative health technology company providing innovative solutions in the area of molecular diagnostics, today announced that it has submitted its Emergency Use Authorization (EUA) application for review to the Food and Drug Administration. (FDA) of the United States for its point-of-care (POC) molecular diagnostic test for COVID-19 (SARS-CoV-2). If licensed, the Proof Lab Test System would be the first POC system using CRISPR-based nucleic acid detection, providing a cost-effective, user-friendly, and easily scalable test. The company’s hope is to enable clinicians and patients to achieve lab-level sensitivity and specificity at POC in as little as 18 minutes.
Proof Diagnostics was founded in May 2020 to help people stay safe during the pandemic by providing a cost-effective, fast and accurate COVID-19 testing platform. Over the past 18 months, the company has developed a robust and scalable testing solution by advancing the CRISPR-based diagnostic method STOPCovid developed by world-renowned CRISPR diagnostic pioneers Feng-Zhangdoctorate, Omar Abudayyehdoctorate, Jonathan Gootenberg, Ph.D. and colleagues. Teaming up with an entrepreneur Sid Shenai, CEO, the company obtained a STOPCovid license from the Broad Institute at the end of 2020, improved it and developed a small portable smart device, as well as software and cloud infrastructure. The research was supported by the NIH’s RADx program, DARPA, and the Gates Foundation. Additionally, Proof raised $45 million to date with investors such as ARCH Venture Partners, F-Prime Capital and Madrona Venture Group.
“Delivering a new chemistry, combined with Proof’s innovative technology platform, to EUA submission to the FDA in less than two years is no small feat. CRISPR has long promised to make a difference in people’s lives and we are incredibly proud of the scientific innovation that our team has developed. We hope the FDA will clear our CRISPR-based test so that we can empower communities to take their next step in person with confidence and peace of mind,” said Omar Abudayyehco-founder of Proof Diagnostics.
“Submitting our EUA to the Food and Drug Administration is a significant achievement for Proof Diagnostics as we embark on the future of rapid, at-home POC testing, ensuring optimal accuracy to help detect disease before demonstration of The Proof lab test system has the potential to become a valuable tool for clinicians and patients to make more informed healthcare decisions that can help prevent the spread of disease,” said Sid Shenai, co-founder and CEO of Proof Diagnostics. “The passion and dedication of our team here, and of all our partners, cannot go unnoticed. We would like to thank everyone who made this step possible and we will continue to promote a vision for accessible healthcare.
To learn more about Proof Diagnostics and its vision to improve global public health by staying at the forefront of infectious disease detection, visit www.proofdx.com.
About Evidence Diagnostics:
Proof Diagnostics, Inc. has established itself as an innovative health technology company focused on providing innovative solutions in molecular diagnostics. Proof’s mission is to empower the public to take control and better understand their overall health through laboratory-grade molecular testing, starting with COVID-19, that is easy to use, accurate, and cost-effective. The Proof Lab Reader is a portable and scalable diagnostic device that uses a Proof Lab test cartridge and a Proof Lab test kit to deliver lab-quality results and actionable diagnostic information, helping people lead better lives and healthier.
SOURCE Evidence Diagnostics